Laryngeal mask with retractable rigid tab and means for ventilation and intubation

ABSTRACT

A laryngeal mask that comprises a first element which is a rigid hollow tube essentially in the form of “J”, and which has a lengthwise opening along its entire length, and a second element that comprises a flexible tube, also essentially in the form of a “J”, intended to be housed in the lengthwise opening of the first element, and which can be separated from it. This provides a configuration for a laryngeal mask that can change from having rigid properties to flexible ones at the doctor&#39;s will, without the need to interrupt the patient&#39;s supply of oxygen at any time.

TECHNICAL FIELD

The present invention is within the field of anaesthesia for both theinitial anaesthesia phase and the intermediate or late anaesthesia phaseand in both the ventilation mode and intubation mode for administeringoxygen to the patient.

The purpose of the invention is focused on a laryngeal video mask thatallows such interventions to take place under much more advantageousconditions than those currently existing in the state of the art sinceits properties can be changed from rigid to flexible at any timeaccording to the needs related to administration of the anaesthesia. Forexample, if the anaesthesia is in its initial moments a rigid system isrequired, while after the anaesthesia has passed beyond those initialmoments and is in its intermediate or final moments of the surgicalintervention, a soft and flexible system is then required. The laryngealvideo mask proposed also allows such interventions to take place undermuch more advantageous conditions compared to those that currently existin the state of the art, by allowing oxygenation of the patient in boththe ventilation and/or intubation mode according to the clinical needsof the patient. Throughout its entire process of use, whether in rigidor flexible mode as well as in ventilation mode or intubation mode, acontinuous view of the airway can be maintained at all times during theanaesthesia, thanks to its optical systems. These comprise an opticallens integrated into the laryngeal video mask, an optical lensintegrated into the distal portion of the viewing system, a video cameraviewing system, an illumination system, and an integratedanti-condensation system.

STATE OF THE ART

Administration of oxygen to the patient is one of the anaesthetist'spriorities when providing anaesthesia to the patient during surgery. Theanaesthetist can administer oxygen to the patient once the patient isunconscious in ventilation mode or if can be administered to theunconscious patient in intubation mode. If the patient does not have apre-existing illness and if the surgery is not complicated and is ofshort duration, the ventilation devices typically used to administeroxygen to the patient are those such as laryngeal masks with a distalinflatable or gel ring. However, if the patient has many pre-existingillnesses, if the surgery is complicated and involves vital organs, ifit is of long duration, or if the patient will later be transferred tothe hospital's Intensive Care Unit, intubation devices such aslaryngoscopes are typically used to introduce an endotracheal tube intothe trachea in order to administer oxygen to the patient.

However, if based upon the patient's clinical condition the doctorchooses to begin to administer the anaesthesia with one means ofventilation or intubation but then for various reasons the situationbecomes complicated and the manoeuvre cannot be correctly performed andif oxygen therefore cannot be administered to the patient, the doctorwill have a very serious problem. The patient could die if theoxygenation is not restored in about five minutes.

For example, if the doctor has chosen a means of intubation such as witha laryngoscope but the intubation procedure is not performed correctlyand the administration of oxygen to the patient fails, the oxygenationmust be restored using a means of ventilation such as a laryngeal maskwith an inflatable ring or gel ring. The first means (the laryngoscope)must be removed and then the means of ventilation such as the laryngealmask with inflatable ring or gel ring must immediately be introduced.Many minutes are lost in this manoeuvre and it is very risky for thepatient since if is necessary to first remove the initial intubationdevice, then to look for a recovery device such as a laryngeal mask,then to introduce this recovery device correctly into the patient'slarynx, and finally to ventilate and administer oxygen, etc. All of thiscan cause the greater part of those approximately five minutes to belost and during this time the patient's brain may be without oxygen anddeath can later result.

Conversely, if the doctor has chosen a means of ventilation such as alaryngeal mask with inflatable ring or gel ring for intubation but theventilation procedure cannot be performed correctly and theadministration of oxygen to the patient fails, oxygenation must berestored with a means of intubation such as a laryngoscope, by removingthe laryngeal mask and immediately introducing the laryngoscope. Severalminutes are also lost in this manoeuvre and it is very risky for thepatient since it is necessary to first remove the initial ventilationdevice, then to look for a recovery intubation device such as alaryngoscope, then to introduce this recovery device correctly into thepatient's larynx, then to intube with an endotracheal tube andadminister oxygen, etc. All of this can cause the greater part of thoseapproximately five minutes to be lost, and during this time thepatient's brain may be without oxygen and death can later result.

Also, the devices that currently exist in the state of the art eitherhave rigid physical properties or soft and flexible physical properties.Devices such as laryngoscopes typically have rigid properties and theyare therefore good for the initial phase of anaesthesia; in other words,for the initial moments. Because of their rigidity they can be easilyintroduced and placed in their correct position in the airway and theyalso allow the tissues of the airway to be separated towards the sides.In this way the endotracheal tube can be introduced from the exterior ofthe mouth towards the interior of the airway and then past the vocalcords towards the trachea. The primary inconvenience of these rigidlaryngoscopes is that they cannot be kept inside the patient's airwayfor a long time, since their rigid properties put pressure on soft areasof the airway tissues causing injuries and sores. For this reason, a fewminutes after intubation these laryngoscopes must be removed, leaving intheir place a soft or flexible endotracheal tube made of PVC or siliconein order to administer oxygen to the patient.

On the other hand, laryngeal mask type devices with an inflatable ringor gel ring have soft and flexible properties and they are thereforegood for use during the administration of anaesthesia after the initialphase; in other words, for the intermediate or final phases of theanaesthesia, because their soft and flexible properties allow them to bekept inside of the patient's airway for a much longer period of time incontact with the airway's soft tissues where they do not producepressure, injuries, or sores during administration of oxygen to thepatient.

However, these devices have the disadvantage that their soft andflexible properties make them difficult to insert, direct, and place intheir correct position inside of the patient's airway. This is due tothe fact that, because of their soft and flexible properties, the forcesthat the doctor exerts on the proximal part of these devices from theoutside of the mouth are not transferred to the distal part of thedevice introduced into the airway, which makes it difficult to directthem and place them in their correct position.

There is therefore no anaesthesia device in the state of the art thatcan at the same time change from rigid mode to soft and flexible mode,and vice-versa, and which allows both ventilation in laryngeal mask modeand intubation in laryngoscope mode with the same device, without theneed to lose valuable time in removing one device and introducinganother device to restore oxygenation to the patient.

Finally, there are some existing combined devices where a laryngeal maskis combined with one or more integrated channels, with one of these ableto perform the function of oxygen administration while at the same timeacting as a guide for an endotracheal tube. There are combined devicesof this type existing in the prior art, for example, based upondocuments EP 1 938 855 A1, US2003/0192548 A1, US 2001/0012923 A1, U.S.Pat. No. 5,303,697, or US 2004/0020491 A1. However, in all of thesecases the channels in the laryngeal mask are totally integrated in aninseparable manner, with no provision being made for their separation.

In GB 2 324 040 A a laryngeal mask is described with just a singlehollow, tubular body of sufficient size to allow oxygenation of thepatient and for the passage of an endotracheal tube in its interior. Inthis case the possibility of removing the mask while keeping theendotracheal tube inserted in the patient's larynx is considered.However, since the tubular body is flexible, hollow, and closed alongits entire length from the inflatable ring until the proximal part thatremains at the outside of the teeth. For this purpose it requiresspecial retention and external pushing pieces and in the end thelaryngeal mask is removed completely, including the laryngeal ring.

Combined systems of laryngeal masks and endotracheal tubes are alsodescribed in documents such as US 2007/02407(22) A1 and U.S. Pat. No.5,623,921. However, in the first case there are two flexible tubularbodies that are hollow and closed along their entire length from thetrachea until the outside of the teeth. One of these goes towards thetrachea and the other towards the oesophagus and the possibility ofremoving the laryngeal mask, while leaving only the endotracheal tubeinserted into the patient's larynx is not considered. In the second casethere is such a possibility, by splitting or separating the laryngealmask's tube into two parts along its entire length. This includes thepart that is inserted into the patient's larynx. This could involvedifficulties in practice. Also, in both cases removal of the entirelaryngeal mask involves the removal of the laryngeal ring also.

Finally, document US 2004/0079(36)4 A1 presents a type of laryngeal maskwith an inflatable ring. The mask is rigid and has a rigid tubular bodythat is hollow and closed along its entire length, from the tracheauntil the outside of the teeth. This body allows oxygenation to occurand an endotracheal tube can be passed concentrically through theinterior of the laryngeal mask's tube. This mask is used to restoreoxygenation to patients when intubation with a laryngoscope has not beenpossible. Since it is rigid, it is used for short periods of time torestore the patient's oxygenation by ventilation, and it is alsopossible to pass an endotracheal tube through its rigid channel so thatlater, because of its rigidity, this type of laryngeal mask withinflatable ring can be removed in order to avoid putting pressure on thesoft tissues and causing injuries and sores in the patient's airway.However, in this apparatus, because of the fact that the endotrachealtube is concentric with the rigid channel which is closed along itsentire length, extraction of said rigid channel is not a simple task. Itin fact involves disconnection of the oxygen administered to the patientfor a few moments. Special retention and external pushing pieces arealso required for this. Also, when it is removed the inflatable ring isalso removed although it would be desirable to keep it in place incertain cases. Finally, this device also lacks a means of viewing aswell as an integrated anti-condensation system which means that theentire process is performed blind. Since there is no viewing possibleduring manoeuvring for ventilation or for intubation there are risksinvolved in terms of failure to place it properly and failure of theventilation and also a risk of performing an oesophageal intubation,which represents a great risk to the life of the patient.

None of these documents allow the rigid parts of the device to beremoved from the patient's larynx in a simple and rapid manoeuvre andvice-versa, leaving only the soft parts inside of the patient's larynx.This would prevent the development of wounds and sores in the softtissues of the airway while also avoiding the need to interrupt thesupply of oxygen to the patient at all times. This manoeuvre can also beperformed in the reverse direction, reintroducing the rigid part of thedevice and sliding it around the flexible part from the outside of themouth until the interior of the patient's glottis so that it will againhave rigid properties according to the clinical needs of the patient.For example, in the case of an emergency reintubation after the patienthas regained consciousness after surgery is completed. Furthermore, noneof these allow the laryngeal mask's inflatable ring to be left inside ofthe patient's larynx after this manoeuvre, although this can be highlydesirable in certain cases. Finally, none of these have the meansavailable for viewing the interior of the larynx with an integratedanti-condensation system. This would allow interior inspection to serveas a guide for the doctor when directing the tube towards its correctposition inside of the larynx.

Therefore, the problem to be resolved by the person skilled in the artis to provide a laryngeal mask that overcomes the problems existing inthe prior art and which in particular will allow the two functions ofventilation and intubation to be performed in an interchangeable andreversible manner, without stopping the administration of oxygen to thepatient. More specifically, the problem to be resolved for the personskilled in the art is that of providing a laryngeal mask that could bechanged from rigid mode to soft and flexible mode and vice-versa, at thewill of the operator and in a reversible manner. It must also allowventilation in laryngeal mask mode and intubation in laryngoscope modeusing the same device, without losing valuable time while removing onedevice and introducing the other device to restore oxygenation to thepatient, since during this time the patient would be without an oxygensupply to the lungs.

Another objective of the invention consists of providing a laryngoscopethat allows the doctor to inspect the inside of the larynx in a mannersuch that this would serve as a guide when directing the tube towardsits proper position inside the larynx.

One further objective of the invention consists of preventingcondensation from being deposited on the lenses that make up said meansof inspecting the inside of the larynx in a laryngoscope provided withsuch means of inspection.

The present inventors have found that these problems can be resolvedusing a laryngeal mask that has two main components: A first componentor rigid tube (10), essentially in the form of a “J” and lengthwise openalong its entire length. This lengthwise opening is intended to house asecond component or flexible tube (20) of a laryngeal mask inside whichterminates at its distal end in an inflatable or gel ring (21). Thisarrangement allows the doctor to comfortably insert the invention'slaryngeal mask assembly into the patient's larynx since the assembly isrigid and can be directed and positioned in its proper location withprecision and comfort. Once the assembly with both components has beenpositioned and given that the two components can be separated, the rigidtube (10) can be easily removed from the larynx, leaving only thelaryngeal mask with its flexible tube (20) inside which terminates atits distal end at the inflatable or gel ring (21). Due to its softnessand flexibility it can remain in the patient's larynx for a long periodof time without causing injuries.

In a preferred embodiment, the invention's laryngeal mask also comprisessome optical viewing means (30) intended to transmit the image of theinterior of the larynx to the doctor or operator outside. These meanstypically comprise:

-   -   a system of optical lenses (35) to capture the image with this        system located in the distal end (33) of a flexible tube (32)        that contains in its interior the means of transport (cables,        fibre optics, etc.) needed to transmit the image from the system        of optical lenses to the mini-video camera (37);    -   a mini video camera (37) also located in the distal end (33) of        the flexible tube (32);    -   a illumination system (38 b) for the entire assembly located in        the distal end (33) of said flexible tube (32), as well as a        screen or monitor (31) where the images captured by the        mini-video camera (37) are displayed.

There is also an optical lens system (36) that operates in conjunctionwith the viewing means described above in order to capture the image andwhich are located in the distal end of the channel (26) of the flexibletube (20).

In another embodiment, the system also comprises an integrated system toremove the condensation that may form on the lens system for the opticalviewing means during ventilation or intubation procedures.

An additional advantage of the present invention is that the distal endof the rigid tube (10) has, in preferred embodiments, a tongue-shapedtab (11), also rigid, which allows soft tissues such as the tongue to bemoved aside during introduction of the device into the patient's airway.It also lifts the patient's epiglottis so that it cannot obstruct thepassage of the endotracheal tube towards the glottis and, as the casemay be, prevents obstruction of the view of the optical viewing means(30) that capture the image from the optical lens that transmits theinterior view of the larynx to the video camera. It also preventsobstruction of the flow of oxygen from the exterior towards thepatient's lungs.

Once the mask is in its correct location and therefore viewing of theinterior of the larynx is no longer required, it is possible to easilyremove the tube that contains the optical lens system (30) and, as thecase may be, the optical viewing means and the video camera (37), aswell as the rigid tube (10) with its rigid distal tongue-shaped tab(11). This takes place in a manner such that what remains inside of thelarynx for ventilation of the patient is the flexible laryngeal mask(20) with its flexible sleeve (23) that surrounds the rigid tongue tab(11) and the inflatable ring (21) but without the rigid tongue-shapedtab lifting the epiglottis, in this way, the invented device alsoincludes the function of the tongue-shaped tab lifting the epiglottiswhich is removable when the doctor requires. When the rigidtongue-shaped tab is removed a flexible sleeve (23) that is covered bythe rigid tongue-shaped tab (11) would remain. It has its same shape andis attached to the flexible laryngeal mask.

Another important advantage of devices that are flexible and at the sametime rigid like the Laryngeal Video mask (LVM), and explained as one ofthe preferred embodiments of the invention, is that if the head of apatient with a rigid model of laryngeal mask is moved during surgery,either by need or due to an unexpected situation, this exterior movementis transmitted to the interior. The laryngeal mask's ring will move andbe displaced from its correct location to an incorrect one where thepatient cannot be ventilated, it is important for optimal oxygenationthat during administration of the anaesthesia the ring is not displacedfrom its correct position. This does not occur with the laryngeal videomask in flexible mode because based upon the clinical needs it can betransformed from rigid to flexible and vice-versa and it also has ameans of viewing.

BRIEF DESCRIPTIONS OF THE FIGURES

FIG. 1: Side view of the laryngeal mask assembly with the threecomponents joined: Rigid tube (10), flexible tube (20), and viewingmeans (30). In this view the endotracheal tube (40) is seen housed inits guide channel (25).

FIG. 2: Perspective view of the laryngeal mask assembly with the threecomponents joined: Rigid tube (10), flexible tube (20), and viewingmeans (30). In this view the endotracheal tube (40) is seen housed inits guide channel (25).

FIG. 3: Side view of the laryngeal mask assembly with the rigid tube(10) halfway through the separation phase from the flexible tube (20),which also has the viewing means (30) housed in one of its channels. Inthis view the endotracheal tube (40) is seen housed in its guide channel(25).

FIG. 4: Perspective view of the laryngeal mask assembly with the rigidtube (10) halfway through the separation phase from the flexible tube(20), which also has the viewing means (30) housed in one of itschannels. In this view, the endotracheal tube (40) is seen housed in itsguide channel (25).

FIG. 5: Perspective view of the rigid tube (10) with the upper rigidtongue-shaped tab (11) and an additional lower rigid tongue-shaped tab(13), where the lower guide rails (14) are going to stop. The proximalassembly area (15) for the viewing means (30) is also seen.

FIG. 6: Rear view of the rigid tube (10). The lower rigid tongue-shapedtab (13) and the upper rigid rails (12) are seen, as well as theproximal assembly area (15) for the viewing means (30).

FIG. 7: Side view of the rigid tube (10) with the upper rigidtongue-shaped tab (11) and the lower rigid tongue-shaped tab (13), withthe upper guide rails (12) and the lower guide rails (14) also visible.The proximal assembly area (15) for the viewing means (30) is also seen.

FIG. 8: Perspective view of the flexible tube (20), which has a proximalstraight portion, a central curved portion, and a distal inflatable ringor non-inflatable gel ring (21). The four optional channels are seen inthe embodiment shown and in the various embodiments any of these may bepresent independent of the others:

-   -   a guide channel (25) for the endotracheal tube (40), which is        divided into two sections: one open lengthwise (25 a) and the        other which is not (25 b);    -   the guide channel (26) for the viewing means (30); this channel        (26) has an integrated optical lens that is attached distally to        the end of said channel;    -   the guide channel (27) for aspirating secretions from the distal        surface of the integrated optical lens attached distally to the        guide channel (26) for the optical means; and    -   the guide channel (28) for the oesophageal aspiration probe,        which ends distally in a protuberance (22) that will be the        closure area for the oesophageal sphincter.

Also seen within the ring (21) is the flexible sleeve (23), joined bythe internal part to the proximal area of the ring (21), which willcover the rigid tongue-shaped tab (11) when the rigid tube (10) iscoupled with the flexible tube (20). The flexible sleeve continuesdistally with two elongations (24) that will be joined distally to theinternal area of the ring (21).

FIG. 9: Front view of the flexible tube (20), which has a proximalstraight portion, a central curved portion, and a distal inflatable ringor non-inflatable gel ring (21). Four optional channels present in theembodiment shown are seen, and in the various embodiments any of thesemay be present independent of the others:

-   -   the guide channel (25) for the endotracheal tube (40);    -   the guide channel (26) for the viewing means (30); this channel        (26) has an integrated optical lens that is attached distally to        the end of said channel;    -   the guide channel (27) for aspirating secretions from the distal        surface of the integrated optical lens attached distally to the        guide channel (26) for the optical means; and    -   the guide channel (28) for the oesophageal aspiration probe,        which ends distally in a protuberance (22) that can serve as the        closure area for the oesophageal sphincter.

FIG. 10: Upper view of the flexible tube (20), which has a proximalstraight portion, a central curving portion, and a distal inflatablering or non-inflatable gel ring (21). The four optional channels presentin this embodiment are seen, and in the various embodiments any of thesemay be present independent of the others:

-   -   a guide channel (25) for the endotracheal tube (40), which is        divided into two sections: one open lengthwise (25 a) and the        other which is not (25 b);    -   the guide channel (26) for the viewing means (30); this channel        (26) has an integrated optical lens that is attached distally to        the end of said channel;    -   the guide channel (27) for aspirating secretions from the distal        surface of the integrated optical lens attached distally to the        guide channel (26) for the optical means; and    -   the guide channel (28) for the oesophageal aspiration probe,        which ends distally in a protuberance (22) that can serve as the        closure for the oesophageal sphincter.

Also seen within the ring (21) is the flexible sleeve (23), joined byits internal part to the proximal area of the ring (21), which willcover the rigid tongue-shaped tab (11) when the rigid tube (10) iscoupled with the flexible tube (20). The flexible sleeve continuesdistally with two elongations (24) that will be joined distally to theinternal area of the ring (21). Also seen within the ring are some“pushers” or projections (29) that will serve to direct the endotrachealtube towards the central axis of the ring (21) and which will also serveto prevent the collapse of the laryngeal mask in the vertical direction.

FIG. 11: Perspective view of the flexible tube (20) where thecompartment (50) is seen, intended to house the batteries (51) that willsupply power for the entire device. This compartment is coupled andjoined to the proximal part of the flexible tube (26) by means of ajoining area (53). This compartment (50) also has a joining area (52)with the viewing means (30), preferably hollow, and through which theflexible tube (32) for the viewing means (30) passes. This compartment(50) has a joining area (54) with the monitor (31), through which theelectricity required by the device will be transmitted.

FIG. 12: Perspective view of the viewing means (30), which in theembodiment shown is made up of a monitor (31), a flexible tube (32), anda distal area (33) for housing the camera, the illumination elements,and an optical lens.

FIG. 13: Side view of the viewing means (30), which in the embodimentshown are made up of a monitor (31), a flexible tube (32) with a distaltubular area (33) for housing the camera, the illumination elements, andan optical lens.

FIG. 14: Transverse section of the end of the assembly of the laryngealmask, where visible elements include the rigid tube (10), the flexibletube (20), the transmission tube for the viewing means (32), the distalarea (33) of the flexible tube (32) where the optical focusing lenses(35) are located, the video camera (37), the illumination means (38 b),and the inflatable ring (21).

FIG. 15: Expanded portion of FIG. 14, where the elements in FIG. 13 canbe seen in more detail: rigid tube (10), flexible tube (20), inflatablering (21), distal area (33) of the flexible tube (32), video camera (37)comprising its electronics (34) in the proximal area and its optics (38a) in its distal area (38), optical focusing lens (35) that is coupledto the distal area (33) of the flexible tube (32); this optical focusinglens also serves to create the hermetic distal closure (33) for theflexible tube (32); optical focusing lens (36) which is coupled to thedistal area of the flexible tube (26); this optical focusing lens (36)also serves to create the hermetic distal closure for the flexible tube(26). The lens (36) has a projection (36 a) to direct the aspiration ofthe flexible tube (27) downward.

FIG. 16: Expanded portion of FIG. 14 oriented towards the front, wherethe elements in FIG. 14 can be seen in greater detail: rigid tube (10),flexible tube (20), flexible sleeve (23) that surrounds the rigidtongue-shaped tab (11), elongations (24) of the flexible sleeve (23),inflatable or gel ring (21), distal cover (22) for closure of theoesophageal sphincter, which can be hollow so that an aspiration probecan pass through to the oesophagus, guide channel (25) of the flexibletube (20), optics of the video camera (38 a), illumination system (38b).

DETAILED DESCRIPTION OF THE INVENTION

Consequentially, as its primary aspect, the invention is focused on alaryngeal mask comprising the following elements:

-   -   a first element which is a hollow rigid tube (10), essentially        in the form of a “J”, which has a lengthwise opening along its        entire length; and    -   a second element which is a flexible tube (20), also essentially        in the form of a “J”, intended to be housed in the lengthwise        opening of the first element (10) and separable from this        element. This tube terminates at its distal end with an        inflatable or gel larynx ring (21).

In its secondary aspect, the invention is focused on a method forintubation and/or ventilation of a patient using the mask in agreementwith any of the previous claims, characterised by comprising the stagesof:

-   -   a) introducing the laryngeal mask, made up of the first (10) and        second (20) elements joined in a manner such that the resulting        assembly is substantially rigid, into the patient's larynx, and        directing it into the patient's larynx until it is in its        correct position; and    -   b) when the doctor considers it to be appropriate, separating        the first (10) and the second (20) elements, removing the first        rigid element (10) and leaving the second flexible element (20)        in the patient's larynx for ventilation.

The laryngeal mask represented by the invention will be described inmore detail next, making reference to the attached figures.

The Device's Main Elements:

The laryngeal mask of the invention comprises the following two mainelements, specifically:

The first element is a rigid tube (10), essentially in the form of a“J”. This rigid form in the shape of a “J” essentially consists of aninitial slightly curved proximal section followed by a second straightintermediate section and ending in a third curving distal section. Sinceit simulates the anatomy of the patient's airway, this shape facilitatesthe introduction of the laryngeal mask into the airway as well asplacement in its correct position there. Because of this shape it isalso unnecessary to hyper-extend the patient's neck in order to insertthe device. This rigid tube has a lengthwise opening along its entirelength, with this opening intended to house the second element, which isessentially a flexible laryngeal mask (20) made up of a flexible tube(26) that terminates at its distal end with an inflatable or gel ring(21). This flexible tube (26) of the second element (20) also isessentially in the shape of a “J”. It comprises a straight, flexibleproximal section and a curved, flexible distal section that forms aspecific angle with the first section, and which has an inflatable orgel ring (21) at the end. This flexible tube (26) serves to guide theflexible tube (32) with the viewing means (30) of the video camera andthe optical lens system, in those preferred embodiments of the inventionthat contain that system.

Optionally, the second element's (20) flexible tube (26) can also have asecond tube (25) attached, preferentially made of the same material asthe flexible tube, it can be shorter in length and also open lengthwisein its proximal area (25 a) and closed in its distal area (25 b) inorder to serve as a guide channel. This guide channel (25) is intendedto house and serve as a guide for the endotracheal tube (40), itpreferably has the exact dimensions required in order to house an 8.5 mmendotracheal tube, which is the size most commonly used in adults. Also,in one embodiment this guide channel (25) can optionally be provided onone wall of the proximal area (25 a) with a retention system such as theprojection (25 c), in order to prevent the wall (25 a) of the proximalpart of the flexible tube (25) from being displaced laterally, and inthis way allowing the endotracheal tube (40) that runs through theinterior of the channel (25) to be attached. This system can takevarious forms, one of which can be in the form of a projection or bump(25 c), which can run along a groove in the rigid tube (10).

In a preferred embodiment of the invention, the second element (20) isalso provided with a system to separate the tissues of the airway and inthis way to lift the epiglottis according to the anaesthesia needs ofthe patient at the moment. This system to separate the tissues of theairway and elevate the epiglottis is made up of a hollow, soft, andflexible sleeve (23), which becomes rigid when the rigid tongue-shapedtab (11) located in the distal end of the first element's rigid tube isinserted into its interior. In certain embodiments, this flexible sleeve(23) is in turn made up of two layers of flexible material that overlapwith the proximal part of the interior ring (21) of the laryngeal mask(20), distally towards the centre of said interior ring (21). These twoflexible layers can be joined along their entire edge or open at theirmost distal end in the manner of a Heimlich valve, and they can also bejoined with the internal part of the gel ring through the elongations(24).

When the flexible tube (26) of the second element (20) is coupled withthe rigid tube (10) of the first element, the distal end (11) of thetongue-shaped tab of the rigid tube (10), which preferentially has aduckbill shape, is inserted inside the two flexible layers of theflexible sleeve (23) of the laryngeal mask (20), from its proximal todistal parts. In this way, the resulting combined tongue-shaped tabchanges from having flexible properties to rigid properties. This isuseful for separating the airway tissues during the entire length of itstravel towards its final correct position. It also serves to preventthese tissues from interfering with the area visible to the opticalmeans as well as to lift the epiglottis. The rigidity of this systemhelps to actively separate these soft tissues because the movements madeto the first rigid element from the outside are transmitted to theinterior of the laryngeal mask, to its most distal portion at the rigidtongue-shaped duckbill tab. Then, once the anaesthesia process hasadvanced and the rigid first element (10) is removed from the assembly,the tongue-shaped tab (11) of the rigid tube (10) is logically alsoremoved from between the two flexible layers of the flexible sleeve (23)of the laryngeal mask (20), with the sleeve (23) in this way regainingits flexible form. In this flexible form, the sleeve (23) can onlypassively keep the tissues out of the visible area for the opticalmeans, but it cannot serve to actively separate these soft tissues. Thisis because once the rigid tongue-shaped tab is removed the movementsmade from the laryngeal mask's exterior are not transmitted as far asthe flexible sleeve (23), due to the softness of the material of theflexible tube (26) of the second element (20).

In an optional embodiment, these two flexible layers of the flexiblesleeve (23) are joined with the internal area of the ring (21). Thistakes place through two elongations (24) which extend distally from thedistal part of these flexible layers towards the distal part of the ring(21) in the interior of the laryngeal mask (20). These elongations (24)serve to prevent the two flexible layers of the flexible sleeve (23)from falling downwards and impeding the correct vision of the viewingmeans by interfering with their viewing area. They also serve topassively prevent the soft tissues of the airway and the epiglottis fromfalling into the bell of the laryngeal mask. These two elongations (24)can also have various arrangements, but the optimal one is a triangulararrangement. This allows more separation distally without causinginterference in front of the vision area of the optical means and alsoallows passage of the endotracheal tube (40) between them.

The second element (20) can also optionally have a projection or stopper(22) in the distal end of the inflatable or gel ring (21), intended toplug the oesophageal sphincter to prevent the exit of oesophagealmaterial into the airway. This is important because there is a greatrisk caused by materials from the oesophagus being breathed into thelungs and causing pneumonia, which can be fatal in 50% of patients. Thisprojection (22) can be hollow to allow the passage of an aspirationprobe into the oesophagus.

In yet another embodiment, the laryngeal mask's bell is provided with atleast one “pusher” or projection (29) located inside of it, to preventthe vertical collapse of the laryngeal mask caused by the pressure ofthe soft tissues in the patient's airway. Thanks to its orientation itcan also allow the endotracheal tube (40) to be directed towards thecentre of the lengthwise axis of the laryngeal mask device (20), therebypreventing it from heading if in undesired directions and allowing it toenter directly through the centre of the vocal cords.

The Optical Viewing Means and the Anti-Condensation System

To these two main elements (10) and (20), some means for optical viewingare added in preferred embodiments of the invention. These have avariety of functions and advantages: they allow the image to be focusedat an appropriate distance from the vocal cords, they allow the axis ofvision to be aligned with the axis of movement for the endotrachealtube, and the optical focus lens (35) is located in the distal area (33)of the flexible tube (32) which also makes it possible to hermeticallyclose the distal area (33) of the flexible tube (32). Another opticalfocus lens (36) is located in the distal area of the flexible tube (26)and allows hermetic closure of the channel (26) of the flexible tube(20), which is where the viewing means (30) of the laryngeal video maskare housed. This keeps them clean and out of contact with the patient'ssecretions, and prevents the need to resterilise them after each use,allowing them to be used in another case right away.

In a preferred embodiment of the invention the set of optical viewingmeans is made up by: the optical lens (35) located distally (33) in theflexible tube (32) of the viewing means (30), the integrated opticallens (36) attached distally in the channel (26) of the laryngeal mask(20) that houses the viewing means (30), a video camera (37), a monitoror screen (31) with some menu buttons, a flexible hollow tube (32)through which the wires, fibre optics, or any other means oftransmitting the images pass from the lenses to the video camera (37),and the illumination system (38 b), with all of these working togetherplus the anti-condensation system.

The batteries (51) for the device, which provide power for the monitoror screen (31), the video camera system (37), and the illuminationsystem (38 b), are located in a compartment (50). This compartment iscoupled and joined to the proximal part of the flexible tube (26) by ajoining area (53). This compartment (50) also has a joining area (52)with the viewing means (30), which will be hollow and through which theflexible tube (32) for the viewing means (30) will pass. The compartment(50) also has a joining area (54) with the monitor (31) through whichthe electricity required by the device will be transmitted.

In one embodiment the monitor or screen has some buttons to control themenu as well as an optional recording system, with removable SD memorycards and an optional video output connection.

The assembly of the viewing means can optionally transmit the image toanother receiving system by wireless means, for example infrared,Bluetooth, or Wi-Fi,

The set of optical viewing means receives electricity from the batteries(51) that are housed in the compartment (50) and which supply themonitor or screen, the video camera system, and the illumination system.The batteries in the compartment (50) that power the video camera systemand the illumination system create sufficient heat to heat the opticallens (35) located distally (33) in the flexible tube (32) with the meansfor transmitting the images, and this lens (35) heats the integratedoptical lens (36), which is distally attached in the channel (26) of thelaryngeal mask (20). This prevents condensation caused by the change oftemperature that occurs when the device goes from a cold environment toa warm environment with higher humidity, such as the patient's airway.In this configuration the laryngeal mask in the invention can be definedas a laryngeal video mask with optical viewing means and integratedoptical lenses.

The viewing system (30) can be attached or detached from the rest of thesystem by guiding it through the flexible channel (26) of the secondelement or flexible laryngeal mask (20). Also, as mentioned above, thedistal portion of this flexible tube (26) contains the optical lenssystem (36) which will assist with focusing the video camera (37) andwhich will also help align the video camera's (37) viewing axis with thesliding and advancement axis of the endotracheal tube (40). It will beheated to form part of the anti-condensation system.

In preferred embodiments of the invention, the anti-condensation systemwill be located in the distal part (33) of the flexible tube (32), whichcontains the optical lens system (35). The anti-condensation systemintegrated into the laryngeal video mask (20) and the illuminationsystem (38 b) functions by using contact and proximity to heat thedistal optical lens (35) located in the distal end (33) of the flexibletube (32). The optical lens (36) located distally in the channel (26)that guides the flexible tube (32) will also be heated by contact andproximity, increasing its temperature to the temperature of the humanbody and preventing the production of condensation. This condensation iscreated by the difference between the colder temperature outside of thepatient's body and the warmer and more humid conditions inside thepatient's airway.

The System for Aspiration of Oesophageal Secretions

In another preferred embodiment the invention will also include anadditional channel (28) that is closed along its entire length but openat both ends, dedicated to aspiration of oesophageal secretions. Thischannel runs the entire length from the distal part of the inflatable orgel ring (21) of the laryngeal mask (20) to the proximal portion of thelaryngeal mask (20), where it can be coupled with a standard surgicalaspiration system.

The Aspiration System for Secretions on the Optical System for theViewing Means

In another preferred embodiment, the invention also includes anadditional channel (27) closed along its entire length but open at itsdistal end and optionally closed with a plug on its proximal end. Thischannel is dedicated to aspiration of secretions on the distal surfaceof the optical lens (36) located distally in the flexible channel (26)of the laryngeal mask (20). This channel runs the entire distance fromthe distal part of the flexible channel (26), which guides the flexibletube (32) in its interior, to the height of the distal optical lens (36)in the flexible channel (26), then to the proximal part of the laryngealmask (20). At that point it can be coupled to a standard surgicalaspiration system which will allow cleaning of the optics in the eventthat the lens becomes obscured by secretions.

The Oxygen Administration Channel

Optionally, the laryngeal mask in the invention can have a channel (25)or conduit for administration of oxygen, closed along its entire lengthand dedicated or integrated as with the rest of the laryngeal masks onthe market or it can also not be closed along its entire length,dedicated or integrated, and in this case with an open channel (25 a) orconduit along its entire length except for at the distal end (25 b),where a short length will be closed.

In the case where there is not a dedicated or integrated channel orconduit for administration of oxygen but there is a channel or conduitopen along its entire length (25 a) except for at the distal end (25 b),where a short length is closed, an endotracheal tube (40) will be used.This can be any type of standard endotracheal tube manufactured by anyendotracheal tube company, where the channel (25 b) and the endotrachealtube (40) will perform two functions:

-   -   First, to administer oxygen to the patient when this device is        used in ventilation mode, where the pneumatic cuff of the        endotracheal tube (40) is withdrawn or retracted and        strategically located at the height of the distal end of the        short closed length of the oxygen administration channel (25 b),        and when inflated this cuff creates a hermetic closure with the        closed channel (25 b), allowing ventilation of the patient with        positive pressure and without leaks;    -   The second function will be that of using the channel (25 a) or        conduit open along its entire length except for a short distance        closed at its distal end (25 b) to guide the endotracheal tube        through the vocal cords, for intubation of the patient when the        device is used in intubation mode, in order to perform this        intubation manoeuvre the pneumatic cuff of the endotracheal tube        (40) must first be deflated in order to advance the endotracheal        tube into the closed channel (25 b).

An Embodiment of the Invention

In this manner, in agreement with one embodiment of the invention, theflexible part (20) of the device's laryngeal mask has four channels:

-   -   a first channel (28) that is completely closed along its entire        length but open at its two ends for aspiration of oesophageal        secretions,    -   a second channel (27) completely closed along its entire length        but open at its distal end, and closed at its proximal end by a        cover that can be opened only in cases where there is a need to        aspirate secretions from the distal surface of the optical lens        (36) of the laryngeal video mask,    -   a third channel (26) completely closed along its entire length        but open only in its proximal part, where the viewing means (32)        enter, and closed in its distal portion by the optical lens (36)        of the laryngeal video mask, and    -   a fourth channel (25) open along almost its entire length (25 a)        except in its final distal portion, which is closed (25 b), and        also open at both of its ends, and which will serve as a guide        for the standard endotracheal tube (40).

The preferred embodiment of the invention has a rigid part (10) that hasa rigid tongue-shaped tab (11) in its distal part.

The preferred embodiment of the invention has dedicated means of opticalviewing (30) with an integrated anti-condensation system available.

This preferred embodiment of the invention allows standard endotrachealtubes (40) to be used instead of special silicone endotracheal tubes asis the case in other current state of the art products, and it allowsthe use of tubes with an internal diameter as large as the 8.5 mminternal diameter that is the most commonly used size in anaesthesia fora normal adult.

In one embodiment of the invention, the sliding between the laryngealmask's rigid elements (10) and flexible elements (20) for separation ordecoupling or later coupling (if necessary) of the two elements will befacilitated by some rails that will run along the entire length of themidline of both the upper part (12) and lower part (14) of the rigidelement as well as by some grooves of the same size located along themidline of the flexible element (20) of the laryngeal mask.

In one embodiment of the invention, the rigid tongue-shaped tab (11)located in the distal part of the first element (10) of the deviceperforms the function of separating the soft tissues of the airway aswell as the function of lifting the epiglottis. It also has the functionof preventing the horizontal collapse and closure of the laryngealmask's ring (21), which is produced within the patient's airway when theairway's soft tissues close over the ring (21) of the laryngeal mask(20).

In this embodiment of the invention the mode of administering oxygen tothe patient is interchangeable between ventilation mode using theinflatable or gel ring and intubation mode using the endotracheal tubein order to provide more positive pressure to the patient and preventprolonged pressure in the same area in the soft tissues of the airway,and vice-versa.

Procedure for Ventilation Using the Device in a Preferred Embodiment

Prior to introduction of the device into the patient's airway, thestandard endotracheal tube (40) will be withdrawn or retracted into aspecific position in the fourth guide channel (25) in the flexiblelaryngeal mask, so that its pneumatic cuff is positioned precisely inthe closed distal part of the guide channel (25 b). This cuff will beinflated so that a hermetic closure is made with the closed part of thefourth guide channel (25 b), and oxygen for the patient will later beadministered through its interior.

The device is then inserted into the patient's airway using the viewprovided by the optical viewing system (30) with the second flexibleelement (20) coupled in the lengthwise groove in the first rigid element(10), with the viewing means (30) introduced into the third channel (26)of the flexible mask (20) and with the standard endotracheal tube (40)introduced in the fourth guide channel (25), with its cuff inflated tocreate a hermetic closure with the closed channel (25 b).

Once the device is introduced into the patient's airway until reachingits optimal location using the direct viewing provided by the viewingmeans (30), the distal inflatable ring of the laryngeal mask is inflatedin the case of an inflatable ring model. If the model has a gel ringthen the ring would not need to be inflated.

Oxygen is administered by the proximal part of the endotracheal tube(40), and will reach the patient with this device configuration inventilation mode.

If the patient is receiving controlled and stable oxygenation, then therigid element (10) can be decoupled and removed by sliding the rails(12) and (14) along their grooves in the laryngeal mask (20), with onlythe flexible part (20) remaining inside of the patient's airway, andwith the endotracheal tube as a connection for transporting oxygen. Thisprevents pressure on the soft tissues and injuries for the patient.

Here the viewing elements (30) can either be removed or left in theirchannel (26).

Procedure for Intubation Mode Using the Device in a Preferred Embodimentof the Invention

When the doctor requires intubation of the patient with the laryngealvideo mask, this begins from the ventilation mode. Once the patient isreceiving stable oxygenation in ventilation mode, the pneumatic cuff orbail in the endotracheal tube (40) is deflated, and it is advancedtowards the vocal cords until entering the trachea, with continuousviewing during the entire manoeuvre. There the pneumatic cuff or ball inthe endotracheal tube (40) is re-inflated against the tissues of thetrachea, creating a hermetic closure. Oxygen is then provided to thepatient again, now intubed. At this point in time the inflatable ring(21) in the laryngeal mask (20) can be deflated.

Now, when the patient is stable the rigid element (10) can be decoupledand removed by sliding the rails (12) and (14) along their grooves inthe laryngeal mask (20), and the deflated flexible mask (20) and theendotracheal tube (40) can be left in for transmitting oxygen to thepatient.

The flexible element (20) can also be removed, leaving only theendotracheal tube (40) inside of the patient. To do this, the flexibleelement (20) is slid towards the outside of the mouth while at the sametime a finger is used to maintain the position of the endotracheal tube(40) in the mouth and to prevent it from coming out. Since the channel(25 a) is open, the doctor's finger can be used to maintain the positionof the tube (40) until the ring (21) has come out of the mouth and thetube (40) can be grasped at the other end of the ring (21). The closedchannel (25 b) is short in length and its dimensions coincide exactly toallow this extraction manoeuvre to be performed for the flexible mask(20), leaving only the tube (40) in the patient's airway. The tube isfirst held in place by the channel side (25 b) and then held in place bythe ring side (21).

1. A laryngeal video mask comprising the following elements: a rigidtube (10), essentially in the form of a “J”, which has a lengthwiseopening along its entire length; and a flexible tube (20), alsoessentially in the form of a “J”, intended to be housed in thelengthwise opening of the rigid tube (10) and separable from it, andterminating at its distal end with an inflatable or gel laryngeal ring(21).
 2. A laryngeal mask according to claim 1, wherein the rigid tube(10) terminates at its distal end with a rigid tongue-shaped tab (11),and wherein the flexible tube (20) terminates at its distal end with aflexible sleeve (23) intended to house the rigid tongue-shaped tab (11)of the rigid tube (10) in its interior when the rigid tube (10) and theflexible tube (20) are coupled.
 3. A laryngeal mask according to claim2, wherein the flexible sleeve (23) is composed of two flexible layersjoined along their entire outline.
 4. A laryngeal mask according toclaims 2, wherein the flexible sleeve (23) is joined by its distal endto the internal face of the laryngeal ring (21) by means of twoelongations (24).
 5. A laryngeal mask according to claim 1, wherein theflexible tube (20) also has a first guide channel (25) attached,intended to house an endotracheal tube (40) inside thereof.
 6. Alaryngeal mask according to claim 5, wherein the first guide channel(25) intended to house an endotracheal tube (40) in its interior isdivided into one area that is lengthwise open (25 a) and another that isnot open (25 b).
 7. A laryngeal mask according to claim 6, wherein theguide channel (25) is also provided, in the wall of the open area (25a), with a projection (25 c), which can be fit into a groove in therigid tube (10), to prevent the wall (25 a) from becoming laterallydisplaced, allowing the endotracheal tube (40) that runs through theinside of the channel (25) to be held in place.
 8. A laryngeal maskaccording to claim 5, wherein the dimensions of the first guide channel(25) allow an endotracheal tube (40) that has an 8.5 mm internaldiameter to be housed in the interior thereof.
 9. A laryngeal maskaccording to claim 1, wherein the flexible tube (20) further comprises asecond guide channel (26) attached to house the flexible tube (32) ofviewing means (30).
 10. A laryngeal mask according to claim 9, whereinthe second guide channel (26) is provided with an optical lens (36) atits distal end, which is solidly integrated into the guide channel (26).11. A laryngeal mask according to claim 9, wherein the second guidechannel (26) is provided with a compartment (50) at its proximal end,which contains some batteries (51) intended to supply electricity to thecomponents of the mask that require it.
 12. A laryngeal mask accordingto claim 1, wherein the flexible tube (20) also has a third guidechannel (27) attached for aspiration of secretions from the distalsurface of the optical lens (36).
 13. A laryngeal mask according toclaim 1, wherein the flexible tube (20) also has a fourth guide channel(28) attached, intended to house an oesophageal aspiration probe.
 14. Alaryngeal mask according to claim 13, wherein the fourth guide channel(28) terminates distally in a protuberance or plug (22) intended toclose the oesophageal sphincter.
 15. A laryngeal mask according to claim14, wherein the protuberance or plug (22) is provided with an orificethat allows an oesophageal aspiration probe to pass through it.
 16. Alaryngeal mask according to claim 1, wherein the internal face of thelaryngeal ring (21) is further provided with at least one projection(29) intended to direct the endotracheal tube towards the central axisof the ring (21).
 17. A laryngeal mask according to claim 1, which alsocontains viewing means (30) to capture images from the interior of thelarynx and display them on the exterior.
 18. A laryngeal mask accordingto claim 17, wherein the viewing means (30) comprise: a flexible tube(32) intended to be housed in the interior of the second guide channel(26), and which contains means for transmission of images, and whereinsaid flexible tube (32) is provided with an optical focusing lens (35)at its distal end, a video camera (37), and means of illumination (38b), and provided at its proximal end with a monitor (31) for displayingthe images captured by the video camera (37).
 19. A laryngeal maskaccording to claim 18, in which the means contained in the flexible tube(32) for transmitting the images are copper wires or fibre optic.
 20. Alaryngeal mask according to claim 17, in which the monitor (31) isindependent of the mask and where the viewing means (30) comprise meansto send the images captured by the video camera (37) to the monitor (31)in a wireless manner.
 21. A laryngeal mask according to claim 17, inwhich the viewing means (30) also include an anti-condensation systemcomprising a heating/illumination system (38 b) for heating the opticallens (35) located at the distal end of the flexible tube (32), as wellas for heating the optical lens (36) located at the distal end of thesecond guide channel (26).
 22. A mask according to claim 1, in which therigid tube (10) is provided with rails that run along at least part ofits length, and where the flexible tube (20) is provided with groovesthat also run along at least part of its length, intended to facilitatethe coupling and uncoupling of the rigid (10) and flexible (20) tubes.